Z-0479-2016Class II

VAPR TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)

Name: Z-0479-2016 VAPR TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2015-11-23
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2015-11-23 / Terminated / root cause: manufacturing process

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of VAPR TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028) on 2015-11-23. FDA classified it as Class II and gives the reason as "Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring for each button function was confirmed as correct and the non-conformance...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0479-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-23
Posted: 2015-12-23
Terminated: 2017-04-12
Recalling firm: DePuy Mitek, Inc.
Product: VAPR TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring for each button function was confirmed as correct and the non-conformance impacted button color only
Root cause tag: manufacturing process
FDA root cause: Process control
Action: DePuy sent an Urgent Field Safety Notice dated November 23, 2015, mailed FEDEx to all affected Customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were asked to take the following steps: 1. Review inventory located within your facility and quarantine any products listed in this product recall notification. Please follow the instructions on the Business Reply Form to return any affected inventory located in your facility. 2. Review, complete, sign and return the attached business reply form in accordance with the directions on the business reply form within 5 business days of receipt of this notification. 3. Forward this notice to anyone in your facility that needs to be informed. 4. If any potentially affected product has been forwarded to another facility, contact the firm. 5. Keep a copy of this notice. For further questions please call (508) 880-8100.
Quantity in commerce: 127
Distribution: Worldwide Distribution - US Distribution to the states of : AL, CA, CT, FL, KY, MN, MS, ND, NJ, NM and TX., and to the countries of: France, Netherlands and Norway.
Product codes and lots: U1509202 and U1509162

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0479-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0479-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-23

Product code GEI

K143475Class IIVAPR Tripolar Suction ElectrodeDepuy Mitek / cleared 2015-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)